Recombinant DMA Advisory Committee - 
he had not had an opportunity to talk with all subcommittee members. In this respect, 
the views represented were his own. Further, the recommendations contained in his 
report were an effort on his part to put in the form of recommendations, items that were 
discussed and which the Planning Subcommittee would like to have evaluated by the 
RAC. The first recommendation was the only one on which the Planning Subcommittee 
took a vote and is ready for action by the RAC. All others are for discussion and further 
research, not recommendations for action to be taken. 
Mr. Mannix said that the final clarification was that the report did not recommend 
sunsetting the NIH Guidelines or the RAC, but recommends transforming the RAC and 
refocusing it on human gene therapy. The most that the draft report recommends is 
looking around to see if there is another appropriate organization with the means for 
keeping the NIH Guidelines current, in readable form, and available to researchers. 
Dr. R. Murray was grateful to Mr. Mannix for taking the time to compile this report 
since Dr. R. Murray had missed some of the discussion during the meeting due to a 
scheduling conflict. He agreed with some of the points made by Mr. Mannix, but that he 
understood other members of the subcommittee differed in their impressions of some of 
the discussions that took place at the meeting. This report was a good point of 
departure for discussion. The reports of the subcommittees that had been presented so 
far show that there is still a need for the RAC, but that there could be discussion of how 
it should be structured and what should be its focus. 
Dr. B. Murray said that the report reflected Mr. Mannix's opinion, rather than a 
consensus opinion of the subcommittee, and that she did not feel a consensus was 
reached on many items. She said she thought that all the items that were presented in 
the report were discussed and that there were very few specific recommendations to 
make. One issue that was believed to be generally agreed upon was removing 
environmental release from RAC oversight on the basis that it was covered by other 
agencies. She asked for clarification as to whether this indeed was the case. 
Dr. Wivel perceived that the question was whether the RAC should consider keeping the 
trigger in place to require notification of the RAC for environmental release until such 
time as the United States Department of Agriculture (USDA) Guidelines were 
promulgated. It was clear that the Environmental Protection Agency (EPA) and the 
USDA would be the major players in plaimed release experiments. Dr. Wivel said that 
clearly the regulatory agencies would have to take some responsibility for environmental 
release, whether or not the NIH chose to remain in the area. Further, if NIH is to stay 
in the review process there are certain requirements relating to the National 
Environmental Policy Act (NEPA) that involve monitoring and testing, as well as the 
possibility of public hearings. The NIH is not well positioned to undertake such 
activities since this agency lacks any regulatory authority. 
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Recombinant DNA Research, Volume 14 
